Leaders in research came together for a four-day series of Clinical Trial Digital Week 2021 to discuss an evolving need in the research community: hybrid and decentralized clinical trials.
Despite advances across the rest of healthcare over the past 10 years, clinical trial methods have been slow to adopt change. The clinical research industry needed to take a step back and evaluate the methods in which we were running clinical trials, in light of COVID-19’s impact on health system access. Topics included the shift COVID-19 caused in clinical trials, how technology fits in, and how we can best use this shift in research to make clinical trials more diverse and accessible to patients. I learned a lot from this series, and here are some key takeaways.
COVID-19 impacted the way in which we delivered clinical trials, much like the rest of healthcare. As patients were unable to come into the clinic to complete assessments, get blood work drawn, or complete other necessary study parameters, Sites and Sponsors pivoted or paused with the ongoing pandemic. While many trials stalled, a new wave of thinking emerged. Technology platforms like Force Therapeutics captured study endpoints, mobile nurses came to homes, and telehealth emerged. With these adjustments, the convenience for patients to be in a trial completely changed.
Sites and patients alike found that the majority of study parameters can be conducted from the comfort of patients' homes, rather than through disjointed bits of technology. This led to an increase in patients' ability to participate in clinical trials, and ease of follow-ups for patients. With success thus far, sponsors and investigators alike are changing study protocol mindsets to best think through how clinical trials can become more convenient and choice enabling for patients.
While I’ve mentioned the impact decentralized trials can have on patients who are thinking of and enrolled in studies, the use of decentralized hybrid trials has the potential to positively impact all stakeholders from health systems to investigators to sponsors.
With hybrid decentralized trials, stakeholders are able to expand the addressable patient population through siteless studies and increased diversity, speed the rates of enrollment, improve data interoperability and the digitization of health records, and save costs. Less burden falls on research coordinators to try and chase down patients to come back for study visits, and sponsors are seeing higher patient compliance with study endpoints. With an estimated increase of 100-150% use of decentralized and hybrid trials over the next 3-5 years, this wave of change will have a lasting impact on all areas of healthcare.Force participated in a recent webinar with McKinsey in which we discuss how organizations are investing in greater efficiency and engagement tools, making themselves more attractive to the paying stakeholders in their respective markets.
A theme that came up time and time again is that while this change is not completely new for all, this is the first time many sponsors and sites are participating in this change. While this change is exciting, it will take collaboration from sponsors, regulatory bodies, sites, and the patient voice to ensure that not only are these trials successful but that we are able to continue this forward momentum and scale over time. As new technologies come to the table, we have the ability to collect massive amounts of information that the community has never had access to before such as wearable technology.
In the vein of collaboration, it is critical to ensure that regulatory bodies adapt with these changes to maintain data quality and rigor, and sponsors and sites utilize these technologies to create patient-centric and flexible clinical trial protocols. With the correct resources and collaboration between stakeholders, this has the ability to drive healthcare forward through clinical research in a way we have never seen before.
Overall, this wave of change has the ability of improving the patient experience, to accelerate development, enhance the way we’ve traditionally thought of delivery of clinical trials. We are thankful for all speakers and listeners for coming together to become better informed and look forward to seeing how this innovation in research shapes the future of healthcare.
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